Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction
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|ClinicalTrials.gov Identifier: NCT00145041|
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : January 5, 2012
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Drug: Vincristine Sulfate Liposomes Injection||Phase 1|
Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.
Secondary: To assess the safety and antitumor activity of VSLI in this population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||November 2007|
Single armed study; all subjects received VSLI
Drug: Vincristine Sulfate Liposomes Injection
Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
Other Name: Marqibo
- T 1/2 [ Time Frame: cycle 1 day 1 ]The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.
- Clearance [ Time Frame: Day 1 of Cycle 1 ]The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2
- Volume of Distribution [ Time Frame: cycle 1 day 1 ]The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145041
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Agop Bedikian, MD||MD Anderson Cancer Center, Dept of Melanoma|